Pointcare Now Brochure Eng
Pointcare Now Brochure Eng
Pointcare Now Brochure Eng
TM
FDA-CLEARED
1. Draw
2. Test
0 - 8 Minutes
Scan sample ID with barcode reader Simply drop in sealed reagent vials & capped blood sample WALK AWAY!
Read 12 results in one simple report (printed & stored) Reduce loss-to-follow-up
Capped blood-sample tube No exposure risk No pipetting No manual steps Ready-to-use reagents
Automated software interprets raw data No subjective interpretation of dot plots 8,000 results stored on board USB port to transfer results (USB ash drive included)
DESIGNED SPECIFICALLY FOR LOW-RESOURCE SETTINGS, NO OTHER DEVICE OFFERS THE SIMPLICITY, FLEXIBILITY, & IMMEDIACY OF THE POINTCARE NOW SYSTEM
Rugged system with exible power Battery and solar option and
fast, easy set-up for mobile use. Operational for patient testing 20 minutes after transport.
Easy logistics & supply chain with all you need for testing in one box All reagents, Daily Check controls, phlebotomy, and other
necessary supplies required to run 100 patient samples. NO REFRIGERATION REQUIRED!
Serve More Patients, Reduce Loss-to-Follow-Up, & Improve Outcomes with the PointCare NOW System!
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the PointCare NOW system delivers on-the-spot results before the patient leaves the clinic
There is much more to proper management of HIV/AIDS patients than a regular evaluation of T-cell status. It requires assessment, diagnosis, and treatment of underlying health conditions. Thats why the PointCare NOW system delivers 12 results total in one easy report: CD4/CD4% WBC Hemoglobin Lymphocyte, neutrophil, monocyte, eosinophil (count and percent for all) Is it time to initiate or change antiretroviral therapy? Are there indicators of opportunistic infections or parasites? The systems CD4/CD4% and hematology parameters give you greater insight into the patients overall health on the spot, before he leaves the clinic so you can follow up and treat accordingly.
White blood cell count monitoring can help detect opportunistic infection.
Hemoglobin concentration can help identify anemia early to improve health outcomes.
Lymphocyte to monocyte ratio may help ag HIV patients co-infected with tuberculosis.
L Low neutrophils put HIV/AIDS p patients at increased risk for bacterial and fungal infection. b
CD4% is a critical parameter in pediatric and adult care Unlike absolute CD4 values, CD4% values remain constant within the increasing or decreasing lymphocyte population. When viewed together, CD4, CD4%, and lymphocyte can be a more-accurate indicator of immune status than CD4 count alone, facilitating internal cross-checking of each CD4 patient report.
Visit www.pointcare.net/publications/ for more information on the value of the CD4, CD4%, and hematology parameters on the PointCare NOW system, as well as references to relevant medical studies.
Pearson R: 0.924
FACSCountTM
Samples: 81 Sites: 3
* WBC, HGB, NEU, LYM, EOS, MON
P OI N TC A R E NOW PRECI SI ON
The 2008/09 study at the National Public Health Laboratory of Haiti ran a CD4 Low Control 20 times in order to evaluate repeatability. The CD4 count precision (CV) from this study was 13.5% . After the release of PointCare NOW System Version 2 in 2010, PointCare conducted an internal study to reevaluate precision for Low and Normal levels of CD4. Precision (CV) was 9.0% at the Low level, and 4.9% at the Normal level when run 20 times each on two instruments.
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Optional Accessories Portable travel case (holds instrument, printer, barcode reader, power cords, reagents, etc.) Portable battery pack Folding solar panel Required Materials Not Provided None Space Requirements Instrument: Height: 35 cm Width: 25 cm Depth: 34 cm Weight: 12 kg Printer: Height: 14 cm Width: 16 cm Depth: 25 cm Weight: 2.7 kg
Regulatory Status FDA/IVD cleared CLIA moderate-complexity rating CE marked ISO 13485:2003 certied manufacturer UL listed
PRECISION & R EPORTABLE RANGES REPORTABLE RANGE PARAMETER CD4 Count 50 to 6,000 CD4 Count* 3.0 to 77.0 CD4 Percent (%) WBC 0.5 to 40.0 Hemoglobin 1.0 to 20.0 Lymphocyte Count 0.2 to 15.0 Lymphocyte Percent (%) 12.0 to 80.0 Neutrophil Count 0.2 to 23.5 Neutrophil Percent (%) 12.0 to 80.0 Monocyte Count 0.0 to 5.9 Monocyte Percent (%) 1.5 to 20.3 Eosinophil Count 0.0 to 5.8 Eosinophil Percent (%) 0.6 to 60.0
* Determined by CD4NOW Control Low
UNITS
PRECISION LEVEL
CV
600/L 100 to 200/L 6.0 103/L 12 g/dL 2.0 103/L 2.0 103/L 1.0 103/L 0.3 103/L
< 10% < 15% < 3% < 2% < 5% < 3% < 7% < 15%
WBC* Hemoglobin*
7
10 /L g/dL
3
0.999 0.999
0.10% 0.5%
* System linearity for all other parameters traceable to WBC; system carryover below threshold for all other parameters
REAGENT
KIT INFORMATION
and supplies needed for 100 tests: for 100 tests
(Test Kit/Consumables)
PointCare NOW Reagent Kit 100 contains all reagents, controls, 3 CD4NOW 1 CD4NOW LiquiPacks - Containing Gold Pack - Containing diluent colloidal lysing reagent and cleaning solution
gold reagent for CD4 labeling (for 100 tests) tubes, alcohol swabs, gauze pads
- 3 tubes each of Low and Normal levels needles, needle holders, gloves, blood-collection ID labels, waste tablets, printer paper, and ribbon
supplies - Tourniquets,
Note: No cold-chain or refrigeration required. Reagents & controls are not light sensitive
-~
....,
System Operation
Ease of Use: Fully automated Factory calibrated Instrument Software: patient records; unlimited patient records transferable to USB data analysis - No manual gating or data interpretation - No manual steps for pi petting, - Low power consumption incubation, vortexing, etc. or color compensation required Barcode reader & labels - Simple sample tracking and reagent management LED (no laser); no gain adjustments
Menu languages - English, French, Spanish, Portuguese, and Indonesian (in development) User Safety: No exposure - Closed-tube sampling; no exposure to contaminated blood for safe disposal Closed waste handling - All hazardous waste is contained and decontaminated
CUSTOMER SUPPORT At PointCare, we're proud of our record of quality, performance, and customer support We listened to users and designed everything - the PointCare NOW instrument and kits, ordering logistics, service, and support - to make it easy for customers in resource-limited locations. When you purchase a PointCare NOW system, you can count on us to help you be successful. On-site installation services and user training come standard. And help is just a phone call, or e-mail away. Our typical response time is within one business day. Our field-service staff members are strategically located around the globe to support our customers. Call customer support at: 1'1800.346.6906, E-mail: [email protected] or from outside North America: +1 508.281.6925
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WERE A MILE AWAY FROM THE RAINFOREST WHERE THERE ARE MOUNTAIN GORILL AS, RIGHT ON THE BORDER BETWEEN UGANDA AND THE DEMOCRATIC REPUBLIC OF CONGO.
There arent any tarmac roads here, there isnt any public transport, and lots of the patients live a days walk from the hospital. Many of them live a subsistence existence and they cant afford to get here. So we drive to remote communities in our mobile HIV outreach clinic vehicle equipped with the PointCare NOW system, and are up-and-running testing patients within 20 minutes of arrival. Before we had this machine, wed see somebody in the clinic, then wed have to see them on another day to collect a blood sample. We had a system of motorcycle riders that went round all of our outreach sites on a particular day to collect samples. They would have to ride for four hours along a muddy road through the Impenetrable Forest, to a laboratory on the other side, where we could get them tested. It took us three days to get the result, and we couldnt get it back to the patient until we saw them again two weeks later. Now, with this simple piece of technology, we can deal with problems immediately. Were able to diagnose [AIDS] early, manage it early, and keep people living with HIV t and well... weve been able to change HIV from being a death sentence into something that people can live with and lead productive lives. Dr. Paul Williams, Bwindi Community Hospital, Uganda
T H E P O I N T C A R E N O W S Y S T E M A D VA N TA G E
Absolute CD4 T-Cell Count & CD4% Lymphocyte, Neutrophil, Monocyte, Eosinophil (Count and Percent for All) Simultaneous Hematology, CD4, & CD4% No Reagent Cold-Chain or Refrigeration No Reagent Light Sensitivity Easy to Use with Only Minimal Training Fully Automated System No Manual Gating Required No Manual Pipetting Required Extensive Onboard Data Storage & Management Closed and Decontaminated Waste System Simple & Low Power LED Light Source Low Energy Consumption Flexible Electrical Power (Battery/Solar Option) An industry rst
ABOUT POINTCARE TECHNOLOGIES Our mission is to bring appropriate point-ofcare diagnostics to resource-limited settings. We design, manufacture, and market our products to provide clinicians with the rapid results they need to improve patient care. PointCare is a privately held, FDA-registered, ISO-certi ed company.
Ordering information:
Description PointCare NOW System Installation Package (includes instrument, barcode reader, USB ash drive, preventive-maintenance kit, user manual, reusable waste container, on-site installation, & operator training, 1-year limited warranty) PointCare NOW Reagent Kit 100 (contains all reagents, controls, and supplies needed for 100 tests) Uninterruptible Power Supply 110 V Uninterruptible Power Supply 220 V Portable Battery Power System Solar Charge System Part No. 36008
36000
To order, obtain product information, or for any other inquires please contact: Telephone: +1 508.281.6925 Fax: +1 508.281.6930 E-mail: [email protected]
Headquarters: USA PointCare Technologies, Inc. 257 Simarano Drive, Suite 101 Marlborough, MA 01752 USA Telephone: +1 508.281.6925 Fax: +1 508.281.6930 E-mail: [email protected]
www.pointcare.net
Specications subject to change without notice F-291 Rev C 2010 PointCare Technologies, Inc.
Our list of regional ofces and distributors is growing. Check our Web site for the latest contact details at www.pointcare.net/contact, or call +1 508.281.6925.
ISO 13485:2003